EP0719570B1 - Implantierbare Vorrichtung mit Schutzmitteln gegen elektromagnetische Störungen - Google Patents

Implantierbare Vorrichtung mit Schutzmitteln gegen elektromagnetische Störungen Download PDF

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Publication number
EP0719570B1
EP0719570B1 EP95402975A EP95402975A EP0719570B1 EP 0719570 B1 EP0719570 B1 EP 0719570B1 EP 95402975 A EP95402975 A EP 95402975A EP 95402975 A EP95402975 A EP 95402975A EP 0719570 B1 EP0719570 B1 EP 0719570B1
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EP
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Prior art keywords
voltage
implantable device
circuit
transistor
active implantable
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Expired - Lifetime
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EP95402975A
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English (en)
French (fr)
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EP0719570A1 (de
Inventor
Pascal Pons
Renzo Dal Molin
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Sorin CRM SAS
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Ela Medical SAS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3706—Pacemaker parameters

Definitions

  • the invention relates to the protection of active implantable devices, including pacemakers or defibrillators.
  • the invention is applicable to any type of 'active implantable medical device' as defined by the Directive 90/385 / EEC of 20 June 1990 of the Council of the Communities European.
  • Such protection is in particular intended to guarantee operation normal of the implantable device whatever the conditions surrounding, especially in the presence of electromagnetic interference from outside.
  • the implantable device can pick up all kinds of electromagnetic disturbances from various sources such as electric motors, televisions, induction hobs, radiotelephones, gantries detection of access systems or anti-theft protection systems, etc.
  • sources such as electric motors, televisions, induction hobs, radiotelephones, gantries detection of access systems or anti-theft protection systems, etc.
  • medical devices used during interventions such as electrosurgical units, AC cautery instruments, defibrillators, etc.
  • EMI ElectroMagnetic Interference
  • disurbances ElectroMagnetic Interference
  • Another effect of disturbances picked up by the stimulator is the risk of destruction due to excessive voltages or currents introduced in the stimulator circuits; it is therefore absolutely essential to limit the voltages and currents in the cardiac probes by device input.
  • Zener diodes in the form of discrete components attached to the stimulator microcircuit and mounted at the input, where the various probes are connected.
  • These Zener diodes clipping overvoltages that may appear at the input of the stimulator (clipping at the Zener voltage of the diode), the mounting of the diodes being also designed to ensure symmetrical protection to avoid in particular any demodulation effect in the case of high frequency alternative disturbances.
  • Zener diodes added at the input of the pacemaker has the disadvantage of increasing the size stimulator circuits, due to the need to relate to them additional discrete components, in relatively large numbers high (each of the stimulator input / output terminals requiring minus two diodes), which goes against the miniaturization sought, especially in complex devices such as double and triple chamber stimulators, stimulators connected to a sensor control, defibrillators, etc.
  • these diode protection circuits Zener provide satisfactory protection against high voltages related for example to defibrillation shocks.
  • One of the aims of the present invention is to propose a device active implantable, in particular a pacemaker or defibrillator, having protection circuits providing immunity to against electromagnetic disturbances presenting a very wide variety of electrical and spectral characteristics, ensuring thus in all circumstances compliance with the standards of protection more severe.
  • Another object of the invention is to allow the realization of such a device according to a technology implementing nominal voltages weak control, while providing proper protection to the standards in force.
  • Another object of the invention is to contribute to miniaturization of the device, reducing the number of components to a minimum discrete reported protection circuits.
  • Another object of the invention is to propose protection circuits that can be used and adaptable to technologies various integration (e.g. partially bipolar technology and partially CMOS, or monolithic BiCMOS technology).
  • the invention relates to a device of the type known from US-A-4 739 437, that is to say of which at least all the active components means of protection against electromagnetic disturbances of external origin are monolithically integrated components as well as the microcircuit comprising the signal input stages and switching electrodes, and the switching stages include static voltage switches higher than the battery voltage of the device, the device delivering logic signals from control at a voltage lower than the control voltage.
  • the protection means include voltage translating means to raise, in absolute value, the level of the logic control signals at a value compatible with the control voltages of the static switches and greater than or equal to the nominal level of parasitic voltages resulting from electromagnetic disturbances likely to appear on the terminals of the static switches.
  • Figure 1 is a block diagram of one of the microcircuits of a pacemaker, microcircuit which includes switching circuits electrodes, protection and supply.
  • Figure 2 is a diagram showing the different voltages produced in the circuit of figure 1, and in particular the levels between which vary these tensions.
  • FIG. 3 is a detailed diagram showing the structure of the circuit Figure 1.
  • Figure 4 is an enlarged diagram of part of the circuit of Figure 1, showing the dynamic polarization and protection members against overvoltages.
  • FIG. 5 is a detailed diagram of the internal structure of organs of overvoltage protection of the circuits of Figures 1 and 4.
  • the configuration that we will describe corresponds to that of a stimulator double bedroom, but this example is of course by no means limiting, the invention being able to apply equally well to stimulators single or triple chamber, with or without slave stimulators (therefore comprising one or more additional electrodes of measurement of a physiological parameter), to the detection / stimulation part a defibrillator, or even active implantable devices other than cardiac.
  • the reference 10 designates a core on which have been connected various electrodes whose configuration corresponds to that a double chamber pacemaker, namely ear electrodes distal 12 and proximal 14 and distal ventricular electrodes 12 'and proximal 14 '(in this respect, it will be noted that, in the example described, the circuits and elements relating to ventricular detection or stimulation are designated by the same reference number, with addition of a "premium”, that similar homologous circuits and elements for atrial stimulation or detection).
  • the various cardiac electrodes are connected to a first microcircuit 16 of the stimulator.
  • the stimulator housing is periodically connected to the circuit earth, corresponding to terminal 18, in particular in the case of unipolar detection or stimulation.
  • Cardiac electrodes and the case having several electrical states this involves carrying out periodic, controlled switching operations according to a particular sequencing.
  • the ear electrode 12 is connected to a terminal 20 via a stimulation capacitor 22, the terminal 20 being able to be switched by a switch 24 to an external capacitor 26 the other terminal of which is connected to zero potential (designated V DD on the diagram, and corresponding to the positive terminal of the battery), or directly to V DD by another switch 28.
  • the ear electrodes 12 and 14 are also connected to terminals 30 and 32 intended to allow bipolar detection (for differential voltage measurement) of cardiac activity, these limits being decoupled by respective external capacitors 34 and 36 filtering high frequency disturbances (greater than 1 MHz).
  • Switches 38 and 40 switch off (during stimulation) or in circuit (excluding stimulation) an input resistance 42 for the evacuation of residual charges remaining after stimulation at the heart-electrode interface.
  • Switch 44 is on in case of bipolar detection, and blocking in the event of monopolar detection, and the switch 46 operates in reverse. The detected signal is then directed via lines 48 to differential amplifiers of detection (not shown).
  • the microcircuit 16 also includes a switch 50 for the switching on the ear mass (in the case of stimulation); without the corresponding electrode (terminal 32) is connected to the mass via a resistor 52 of about ten megohms allowing to maintain on this terminal 32 a static potential no.
  • the ventricular pacing circuit is the same as that we have just described, the elements 20 'to 52' being identical to the elements 20 to 52 which we have just detailed.
  • the circuit finally comprises a switch 54 intended for setting selective circuit of the housing mass (terminal 18).
  • controlled stimulator they can be possibly supplemented by one or more additional switches, for example, in the case of a stimulator controlled by respiratory activity, to discharge the injection capacitor.
  • Switches can also be provided, for example in the case of an implantable defibrillator.
  • This logic control circuit delivers in particular logic signals 56 for controlling the switches and clock signals 68 used by the microcircuit 16.
  • the switches are transistors N-type MOS whose gate is controlled by a voltage having the particular voltage excursion indicated above and the substrate is connected to a strongly negative supply voltage.
  • the switches are associated with respective voltage translators 58 interposed between unbalanced and weak control signals level applied in 56 and the grids of the corresponding switches.
  • These voltage translators receive various supply voltages V DD , V SS , V CC and V EE produced by a block 60, the structure of which is shown in detail in FIG. 3.
  • This block 60 consisting of elements fully integrated in monolithic form (like all the other elements of the microcircuit 16), is connected to the negative terminal of a battery 62 whose other terminal constitutes the zero reference potential (V DD ) , the external components of the power supply being a capacitor 64 and decoupling capacitors 65 and 67, the roles of which will be explained later.
  • the substantially symmetrical voltages V CC and V EE / V SUB are produced in the following manner by the block 60 illustrated in FIG. 3.
  • Block 60 which receives control clock signals 68 coming from the logic circuit of the stimulator, essentially comprises two sub-assemblies, namely a sub-assembly 70 producing the negative voltage V EE (and therefore V SUB which is directly therefrom derivative) from V PILE , and a subset 72 producing the positive voltage V CC from the voltage V EE produced by the subset 70.
  • the sub-assembly 70 is essentially constituted by a voltage doubling circuit 74, of structure in itself known and shown in FIG. 3 (and which will not be explained any more for this reason).
  • This doubling circuit is formed of a plurality of translators suitably sequenced by the logic signals 68, of associated switches and of the external capacitor 64. It makes it possible to transform the battery voltage V PILE of between - 2.8 V and - 2 , 1 V at a voltage V EE (and therefore a voltage V SUB ) of between - 5.5 V and - 4.1 V.
  • the voltage obtained is supplied via a diode 78 with low threshold voltage, polarized by a current which it is applied to it from an external source (not shown) in order to limit as much as possible any voltage drop at this component.
  • the sub-assembly 72 for its part, produces from V EE a positive voltage V CC of between + 5.3 V and + 3.9 V, for example by means of a circuit of the "charge pump" type comprising a plurality of switches sequenced by the clock signals 68 and associated integrated capacitors 80, according to a diagram in itself known and which will not be explained in more detail for this reason.
  • Such a circuit of the charge pump type is advantageous because, in BiCMOS or bipolar technology with boxes isolated from the substrate, it can be made fully integrated; other alternative embodiments are however possible, for example, in the case of a simple CMOS technology, sampled circuits of the type with level recovery ( clamping ); in this latter hypothesis, it will be necessary to provide as many circuits as there are switches and also to provide a refresh signal for the switches whose passing state must be maintained for the duration of a cycle.
  • the voltage translators 58 which are connected to the various potentials V CC , V DD , V SS and V EE are circuits in themselves known, interposed on each transmission line of the logic control signal and ensuring the amplification and symmetrization of the control voltage V DD / V SS to V CC / V EE , therefore the amplification and symmetrization of the control dynamics of the switches.
  • These voltage translators can be produced in monolithic form fully integrated into the microcircuit 16, therefore with the possibility of a high integration density and therefore of extreme miniaturization.
  • V SUB which is the most negative voltage of the circuit
  • each of the terminals 20, 20 ', 32, 32' and 18 is connected, on the one hand, to the cathode of a diode 94 whose anode is connected to V SUB (the diodes 94 are also visible in the enlarged partial view of FIG. 4).
  • the resistors 52 and 52 ' which connect the terminals 32 and 32' to the housing (terminal 18), make it possible to be free from any possible leakage current.
  • Zener diodes mounted in opposition between each input terminal and ground. These diodes provide symmetrical skimming voltages greater than the Zener voltage, typically voltages higher in absolute value than ⁇ 7 V (hatched areas of the figure 2).
  • the invention proposes to replace these components, which were up to present discrete components added to the circuit, by fully integrated and monolithic protection circuits.
  • These circuits according to the invention are dipoles mounted in the same way as the Zener diodes in opposition to the prior art, and likely to lead current levels comparable to these (several hundreds of milliamps), despite their fully integrated structure and their much smaller footprint.
  • These clipping circuits 98 are equal in number to that of the terminals 20, 20 ', 30, 30', 32, 32 'and are each mounted between the respective terminal and the mass of the case, corresponding to terminal 18.
  • these circuits 98 each have the structure illustrated in FIG. 5, which is a symmetrical head-to-tail structure each of whose halves has two bipolar transistors 100, 102 connected in series, the emitter of transistor 100 being connected to one of the poles 104 of circuit 98, the collector of this transistor 100 being connected to the emitter of transistor 102 and the collector of transistor 102 being connected to the other pole 104 of circuit 98.
  • a resistor 106 is mounted and between the base of the transistor 100 and the collector of transistor 102 are mounted in opposition two (or more) integrated Zener diodes 108, 110 used to define the clipping voltage.
  • the dipole thus formed enters into conduction when the potential difference across its terminals exceeds, in absolute value, 7 V. It then operates as a conduction current amplifier triggered by voltage, can conduct currents between its terminals up to 300 mA and can absorb 3 A peaks for 10 ms. It is therefore able to bear without risk of destruction of disturbances even very strong energy.

Claims (11)

  1. Eine aktive implantierbare Vorrichtung, insbesondere ein Herzschrittmacher oder ein Herzdefibrillator, aufweisend Schutzmittel gegen elektromagnetische Störungen externen Ursprungs,
    wobei diese Schutzmittel aktive Komponenten und passive Komponenten aufweisen, und wobei zumindest alle aktiven Komponenten integrierte Komponenten sind in monolithischer Art, wie auch die Mirkoschaltung (16), welche die Eingangsstufen von Signalen und die Kommutationsstufen von Elektroden aufweist,
    wobei diese Kommutationsstufen statische Schalter aufweisen (24, 24', 28, 28', 38, 38', 40, 40', 44, 44', 46, 46', 50, 50', 54) mit einer Steuerungsspannung (VSUB, VCC), die größer ist als die Spannung (VPILE) der Versorgungsbatterie der Vorrichtung,
    wobei die Vorrichtung logische Steuerungssignale mit einer Spannung (VDD, VSS) liefert, die niedriger ist als die Steuerungsspannung,
    wobei die Vorrichtung dadurch gekennzeichnet ist, dass die Schutzmittel Spannungstranslatorenmittel (58) aufweisen, um im Absolutwert den Pegel der logischen Steuerungssignale auf einen Wert zu erhöhen, der kompatibel ist mit den Steuerungsspannungen der statischen Schalter und höher ist oder gleich dem nominalen Pegel parasitärer Spannungen, die aus elektromagnetischen Störungen resultieren, die in der Lage sind, auf den Anschlussklemmen der statischen Schalter aufzutreten.
  2. Aktive implantierbare Vorrichtung nach Anspruch 1, bei welcher die logischen Steuerungssignale Signale mit einem Pegel sind, der niedriger ist als der nominale Pegel parasitärer Spannungen, wobei die Spannungstranslatorenmittel Steuerungsspannungen liefern, die größer oder gleich sind als der nominale Pegel der parasitären und symmetrischen Spannungen, geeignet um die Phänomene einer Signaldemodulation in dem Fall von Wechselstörungen hoher Frequenz zu vermeiden.
  3. Aktive implantierbare Vorrichtung nach Anspruch 1, bei welcher die Pegel der Steuerungsspannungen, die durch die Translatorenmittel geliefert werden, erzeugt werden durch eine integrierte monolithische Spannungsheberversorgungsschaltung (60).
  4. Aktive implantierbare Vorrichtung nach Anspruch 3, bei welcher die Spannungsheberversorgungsschaltung zumindest eine Schaltung des Typs Ladungspumpe (72) und/oder eine Schaltung des Typs Spannungsverdoppler (70) und/oder eine Schaltung des Abtasttyps mit Pegelwiederherstellung aufweist.
  5. Aktive implantierbare Vorrichtung nach Anspruch 3, bei welcher die Substrate der statischen Schalter auf ein Potential vorgespannt sind, welches dem Pegel der Steuerungsspannung desselben Vorzeichens entspricht, der durch die Spannungsheberversorgungsschaltung (60) geliefert wird.
  6. Aktive implantierbare Vorrichtung nach Anspruch 3, bei welcher die Substrate der statischen Schalter an ihrer Quelle kurzgeschlossen sind.
  7. Aktive implantierbare Vorrichtung nach Anspruch 1, bei welcher die Schutzmittel unter anderem Aufladungsmittel (94) aufweisen, welche ein Bauteil aufweisen, das einerseits mit einer Signalseingangsanschlussklemme verbunden ist, andererseits mit einer Versorgungsleitung, welche ein Potential liefert, entsprechend den Spannungssteuerungspegeln, die durch die Translatorenmittel erzeugt werden, wobei dieses Bauteil geeignet ist, dann zu leiten, wenn die Spannung an der entsprechenden Eingangsanschlussklemme im Absolutwert die Spannung über diese Versorgungsleitung überschreitet, in der Weise, um auf dieser letzteren eine Spannung aufrechtzuerhalten, die im Absolutwert immer die höchste der Schaltung ist, selbst im Fall von Störungen hohen Niveaus.
  8. Aktive implantierbare Vorrichtung nach Anspruch 1, bei welcher die Eingangsstufen der Signale monolithische integrierte Begrenzermittel (98) aufweisen, die einerseits mit einer Signaleingangsanschlussklemme verbunden sind und andererseits mit einem Massepotential der Vorrichtung.
  9. Aktive implantierbare Vorrichtung nach Anspruch 8, bei welcher die Begrenzerschaltung eine Stromverstärker-Kopf-bei-Fuß-Schaltung (100, 102, 106, 108, 110) mit durch die Spannung ausgelöster Leitung aufweist.
  10. Aktive implantierbare Vorrichtung nach Anspruch 9, bei welcher die Begrenzermittel Begrenzerschaltungen (98) aufweisen, die jeweils in integrierter und monolithischer Form einen Dipol mit symmetrischer Kopfbei-Fuß Struktur aufweisen, wovon jede der Hälften einen ersten (100) und einen zweiten (102) bipolaren Transistor aufweisen, die in Serie montiert sind, wobei der Emitter des ersten Transistors verbunden ist mit einem der Pole (104) der Begrenzerschaltung, der Kollektor dieses ersten Transistors verbunden ist mit dem Emitter des zweiten Transistors und der Kollektor des zweiten Transistors verbunden ist mit dem anderen Pol (104) der Begrenzerschaltung, wobei ein Widerstand (106) zwischen der Basis und dem Emitter des ersten Transistors montiert ist und zumindest zwei Zener-Dioden (108, 110) entgegengesetzt zwischen der Basis des ersten Transistors und dem Kollektor des zweiten Transistors montiert sind.
  11. Aktive implantierbare Vorrichtung nach Anspruch 1, bei welcher die aktiven Komponenten der Schutzmittel und die Mikroschaltung auf demselben monolithischen Substrat integriert sind.
EP95402975A 1994-12-30 1995-12-29 Implantierbare Vorrichtung mit Schutzmitteln gegen elektromagnetische Störungen Expired - Lifetime EP0719570B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9415911A FR2728799B1 (fr) 1994-12-30 1994-12-30 Dispositif implantable actif, notamment stimulateur ou defibrillateur cardiaque, comportant des moyens de protection contre les perturbations electromagnetiques d'origine externe
FR9415911 1994-12-30

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EP0719570A1 EP0719570A1 (de) 1996-07-03
EP0719570B1 true EP0719570B1 (de) 2003-04-09

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US (1) US5649965A (de)
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JP (1) JPH08266647A (de)
DE (1) DE69530272T2 (de)
FR (1) FR2728799B1 (de)

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US8977356B2 (en) 2009-02-19 2015-03-10 Cardiac Pacemakers, Inc. Systems and methods for providing arrhythmia therapy in MRI environments
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DE69530272D1 (de) 2003-05-15
DE69530272T2 (de) 2004-03-25
FR2728799B1 (fr) 1997-03-28
JPH08266647A (ja) 1996-10-15
FR2728799A1 (fr) 1996-07-05
US5649965A (en) 1997-07-22
EP0719570A1 (de) 1996-07-03

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